Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Florida Drugmaker Draws FDA Warning for Repackaging, Distribution

The agency noted in an April 2017 inspection that the firm had no quality control unit for its drug repackaging operation, which repackaged over-the-counter transdermal patch drug products in zippered plastic bags. It also lacked written procedures for its repackaging operations or quality control unit tasks.

In response to the inspection observations, the firm sent the agency a quality control procedure that referenced food regulations and had no applicability to drug product manufacturing.

In addition, the facility had no controls or records to prevent product mix-ups during labeling and repackaging. A contract manufacturer provided most of the firm’s bulk deliveries of various transdermal patches. Phase 4 then repackaged the drug products into zippered bags along with the product labels. The drug products were similar in appearance and had no identifying labels, creating a risk of product mix-ups.

The agency also found the lot numbers of the firm’s distributed products were not recorded, making tracking of the products through the marketplace — and recalls — difficult.

In testing, several products were found to be subpotent and one contained nondeclared ingredients, the agency said.